Conformis iTotal CR Knee Replacement Recall: Insert Fit Hazard
Conformis recalls iTotal CR Knee Replacement System model TCR-111-1111-010102 due to medial and lateral polyethylene inserts not securely fitting into the cobalt chrome tray implant.
Recall notice
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Contact the company
What happened, in plain English
Conformis is recalling a specific model of knee replacement system because the plastic inserts don't fit securely into the metal tray. This could lead to complications during surgery or after implantation. Read more at govinfonow.com/recall/66604-conformis-itotal-cr-knee-replacement-recall-insert-fit-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/66604-conformis-itotal-cr-knee-replacement-recall-insert-fit-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0672-2020
Cite this page
“Conformis iTotal CR Knee Replacement Recall: Insert Fit Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66604-conformis-itotal-cr-knee-replacement-recall-insert-fit-hazard. Based on FDA recall #Z-0672-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0672-2020%22&limit=1).
Why it’s dangerous
The medial and lateral polyethylene inserts are designed to fit into the cobalt chrome tray implant. If they don't secure properly, the implant may shift during use, causing pain or requiring additional surgery.
Who’s affected
Patients who received the iTotal CR Knee Replacement System with model number TCR-111-1111-010102 are affected. Those with this specific model are at risk of complications from improper implant fit.
How to tell if you have this one
Check for the model number TCR-111-1111-010102 on the iTotal CR Knee Replacement System. The serial number 0450585 is also associated with this specific recall.
- Brand
Conformis- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number TCR-111-1111-010102 and serial number 0450585 on the knee replacement system.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0672-2020 (October 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0672-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.